cough out

Generic: guaifenesin

Labeler: efficient laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cough out
Generic Name guaifenesin
Labeler efficient laboratories inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

guaifenesin 100 mg/5mL

Manufacturer
Efficient Laboratories Inc.

Identifiers & Regulatory

Product NDC 58593-255
Product ID 58593-255_37db956a-258a-9804-e063-6394a90aa2b4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 1997-07-01
Marketing End 2026-10-31

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58593255
Hyphenated Format 58593-255

Supplemental Identifiers

RxCUI
310604 1099024
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cough out (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 178 mL in 1 BOTTLE (58593-255-06)
source: ndc

Packages (1)

58593-255-06 178 mL in 1 BOTTLE (58593-255-06)

Ingredients (1)

guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Cough Out ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37db956a-258a-9804-e063-6394a90aa2b4", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310604", "1099024"], "spl_set_id": ["fe4c3921-8d30-4cd6-ba90-9211b362a38a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Efficient Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "178 mL in 1 BOTTLE (58593-255-06)", "package_ndc": "58593-255-06", "marketing_end_date": "20261031", "marketing_start_date": "19970701"}], "brand_name": "Cough Out", "product_id": "58593-255_37db956a-258a-9804-e063-6394a90aa2b4", "dosage_form": "LIQUID", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58593-255", "generic_name": "Guaifenesin", "labeler_name": "Efficient Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough Out", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261031", "marketing_start_date": "19970701"}